(204 days)
The Polyisoprene Powder Free Surgical Glove is a disposable device that is intended to be worn the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations.
The Polyisoprene Powder Free Surgical Underglove is a disposable device that is intended to be worn the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations.
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I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance for "Polyisoprene Powder Free Surgical Glove" or "Polyisoprene Powder Free Surgical Underglove". The document is an FDA 510(k) clearance letter and an Indications for Use statement, which confirms the device is substantially equivalent to legally marketed predicate devices and describes its intended use. It does not include details on specific performance studies or acceptance criteria beyond general regulatory compliance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).